Cystic Fibrosis

Aradigm Corp. drops 54% in pre-market trade on results of two late-stage clinical trialsAradigm Corp. shares fell as much as 54% in pre-market trade Thursday after the company announced topline results from two late-stage clinical trials for its Pulmaquin treatment. Pulmaquin, a once daily ciprofloxacin for inhalation for patients with non-cystic fibrosis bronchiectasis with chronic lung infections with Pseudomonas aeruginosa, had statistically significant results in one late-stage trial but not in the other, the company said. Aradigm said that the analyses of combined data from both studies represented statistically significant outcomes, and called the results "exciting," but investors disagreed with the company's take and sent shares, which closed at $5.24 on Wednesday, plummeting. Aradigm shares rose 31.2% year-to-date, compared with a 7.6% rise in the S&P 500 .

Nivalis' stock loses half its value after failed trial prompts analyst downgradesShares of Nivalis Therapeutics Inc. plunged 53% toward a record low in premarket trade Tuesday, after a Phase 2 trial of its cystic fibrosis treatment failed its primary endpoint. Although the two doses of cavosonstat were well tolerated, they failed to show an improvement in lung function. The company said it plans to continue to investigate the potential of cavosonstat. But RW Baird analyst Brian Skorney followed by downgraded Nivalis to neutral from outperform, saying he believes "the absence of any clinical effect indicates that cavosonstat isn't a relevant drug for cystic fibrosis." Analyst Thomas Shrader at Stifel Nicolaus cut his rating to hold from buy, saying that while Nivalis has indicated it has backup compounds to cavosonstat, the efficacy signals suggest "the therapeutic premise may be dead." The stock, which went public on June 17, 2015 at an initial public offering price of $14, had dropped 19% year to date through Monday, while the iShares Nasdaq Biotechnology ETF had lost 17% and the S&P 500 had gained 7.7%.

Nivalis Therapeutics plummet as cystic fibrosis drug study failsNivalis Therapeutics Inc. shares fell in the extended session Monday after the drug developer said its cystic fibrosis drug failed to reach endpoints in a clinical trial. Nivalis shares, which had been briefly halted, fell 56% to $2.73 after hours. The company said a mid-stage clinical study of its drug cavosonstat did not significantly improve lung function in cystic fibrosis patients when compared to a placebo.

Sarepta may be the real winner from partnership that lifted Summit Therapeutics stock 50% Deal gives Sarepta access to early Duchenne muscular dystrophy treatments Sarepta is a biotech darling after a surprise drug approval.

Vertex Pharma stock drops 5% after company predicts slower Q3Vertex Pharmaceuticals Inc. shares dropped 5.3% in early afternoon trade Wednesday after the company's chief financial officer said the company would see reduced revenue in the third quarter due to slow sales of new cystic fibrosis drug Orkambi. Slow penetration of the drug in Germany, along with an unanticipated "slowdown" in July and August U.S. refills, "obviously... reduces the revenue that we record," CFO Ian Smith said at the Morgan Stanley Global Health Care Conference Wednesday, according to the FactSet transcript. Though U.S. patients were taking less of the drug, which Smith blamed on the summer months, the trend is starting to reverse, he said. RBC Capital Markets continued to rate the stock "outperform," with analyst Michael Yee saying that the slow summer could be a "potential buying opportunity." Vertex stock dropped 1.7% over the last three months, compared with a 2.7% rise in the S&P 500 .

Anthera Pharma stock rises 7% on safety review board's go-ahead for late-stage drug trial Anthera Pharmaceuticals Inc. stock rose 7.3% in pre-market trade Tuesday after the company said an independent expert advisory group gave a positive review of a late-stage clinical trial of its cystic fibrosis drug. The group, the Data and Safety Monitoring Board, said it had "no concerns" with data to date on the phase 3 clinical trial for Sollpura in cystic fibrosis patients with pancreatic insufficiency and voted that the study continue without protocol or charter changes. Shares of Anthera dropped 7.9% over the last three months, compared with a 6.0% rise in the S&P 500 .

We’re in another lousy earnings season, but these companies have grown sales by at least 28% Growing sales is more important that just beating quarterly estimatesGrowing sales is more important that just beating quarterly estimates, says Phil van Doorn.

Vertex Pharma narrows quarterly lossVertex Pharmaceuticals Inc. said its second-quarter loss narrowed, as sales of its cystic fibrosis drugs continued to grow. The Boston-based biopharmaceutical company's top- and bottom-line results beat expectations. Its drug Orkambi, which received U.S. Food and Drug Administration approval roughly a year ago, treats patients with a genetic mutation that is the leading cause of the disease.

Vertex Pharmaceuticals loss narrows as sales surgeVertex Pharmaceuticals Inc. said its first-quarter loss narrowed as revenue surged on continued growth of the biopharmaceutical company's cystic fibrosis drugs. For 2016, the Boston company raised its guidance for sales of its cystic fibrosis drug Kalydeco to between $685 million and $705 million, from its previous estimate of $670 million to $690 million.

This year’s IPOs led by companies with no products or no assets Only biotech and ‘blank-check’ companies have completed IPOsSo far the IPO market has been led by early biotech companies and “blank-check” companies.

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